The Clinical Research Associate works in collaboration with the Principal Investigator (PI) to coordinate assigned minimal risk clinical research studies in accordance with Good Clinical Practice (GCP) guidelines and federal regulations. Work closely with the Principal Investigator [PI] to recruit, screen, consent and enroll participants for studies. Additionally, implement strategies to maintain recruitment and retention rates and assist participants with individual needs. . This position perf
- Assists Investigators with determining patient eligibility for protocols
- Present eligible patients with the appropriate consent and conduct the consent process
- Assists investigators in evaluating compliance to protocol requirements.
- See patients per protocol requirements; provides documentation and schedules required procedures per schedule of events
- Alert Investigators and appropriate staff regarding adverse reactions. Complete (AE) reports according to protocol requirements.
- Maintains or oversees active and follow-up data on all patients enrolled on clinical trials
- Maintains accurate patient files and records for each clinical trial. Ensures current forms and consents are present for each patient. Monitor and update forms and consents as needed.
- Initiate appropriate research procedures, conduct research visits per protocol, completes documentation as per AHS SOP’s
- Assists in review of all patient charts to prepare for audits.
- Develops and completes all source documentation forms as required
- Gather records, reports, radiographs, scans and other necessary data required for institutional site visits/audits. Attends institutional site visits/audits
- Effectively communicate the overall study progress to various internal and/or external stakeholders and identify study trends and create/implement solutions.
- Oversee study compliance with institutional requirements and policies; maintenance of appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record; adverse events [AE] recording and reporting. Oversee Delegation of Authority Logs and training of key personnel on study specific duties.
- Other duties as assigned
Bachelor's degree in health-related field required.
Health care experience plus 1-2 years research experience preferred
SOCRA/ACRP certification preferred
Excellent attention to detail and the ability to keep detailed, accurate records
Strong written and verbal communication skills
Knowledgeable in Microsoft suite, including Outlook Word, Excel, OneNote, etc.
